Phase 1 N=24 Randomized Triple-blind Treatment

A Phase Ib/II in Patients With Acute Ischemic Stroke

Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02963376 ↗

Enrolled (actual)

Serious AEs

11.9%

Results posted

Sep 2021

Primary outcome: Primary: Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities — 0; 0; 0; 0 Dose Limiting Toxicities

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: 0.05 mL/kg DDFPe (Drug); 0.05 mL/kg Placebo (Drug); 0.10 mL/kg DDFPe (Drug); 0.10 mL/kg Placebo (Drug); 0.17 mL/kg DDFPe (Drug); 0.17 mL/kg Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: NuvOx LLC
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities	0; 0; 0; 0; 0; 0	—
SECONDARY NIHSS Assessment	9.5; 6.5; 6.5; 8; 4; 8	—
SECONDARY Modified Rankin Scale (mRS)	2; 2; 2; 3; 1.5; 2.5	—

Summary

Stroke is the fifth leading cause of death in the United States and is the leading cause of long term disability. Distinct geographic disparities in stroke mortality, with highest rates in the southeast United States including Arkansas, are known as the "stroke belt." There the average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the leading cause of serious long-term disability. Between 2012 and 2030, disability and medical costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with the majority of the projected increase in costs arising from those 65 to 79 years of age. There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in 85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond the effective time window for therapy is a common reason for failure. To reduce the devastating impact of stroke on individuals and society, the investigators continue to seek ways to improve functional recovery and limit ischemic damage in stroke patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has recently shown strong positive effects in pre-clinical animal models of acute ischemic stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants and blood substitutes yet none have been successful.

Eligibility Criteria

Inclusion Criteria

Ages 18-80 years
Diagnosis of AIS
Body weight ≥ 45 kg
NIHSS between 2 and 20
Patient or legal authorized representative (LAR) must be willing and able to understand the study and provide written informed consent

Exclusion Criteria

Currently pregnant or breastfeeding

History of significantly impaired renal or hepatic function
Hemorrhage or hemorrhagic stroke on CT scan
Prior stroke, intracranial surgery, or major head trauma within three months prior to enrollment
Pre-stroke modified Rankin Scale (mRS) ≥ 2
Myocardial infarction within six (6) months prior to enrollment
Unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure
Uncontrolled hypertension (SBP > 180 and/or diastolic blood pressure (DBP) > 110 mmHg)
Known long QT syndrome or QTc > 450 milliseconds (ms) in males and > 470 ms in females
Uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six (6) months (except atrial fibrillation)
Clinically significant chronic obstructive pulmonary disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously
Pneumonia, bronchitis, or other acute respiratory disease
Current anticoagulant therapy except for antiplatelet therapy (aspirin, NSAIDs) and prophylactic doses of low molecular weight heparin to prevent deep vein thrombosis. Note: tPA administered as part of subjects' therapy for AIS is allowed.
History of allergic reaction attributed to compounds of similar chemical composition to DDFPe (see Investigator's Brochure).
Subject has received any investigational drug within thirty (30) days prior to enrollment into the study
Inability to comply with the study procedures
History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion

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Data sourced from ClinicalTrials.gov (NCT02963376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.